Entecavir Tablets — Class II drug recall D-0001-2026
Ongoing recall by Zydus Pharmaceuticals (USA) Inc, reported 2025-10-08, distributed nationwide. Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
| Recall number | D-0001-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zydus Pharmaceuticals (USA) Inc, Pennington, NJ, United States |
| Recall initiated | 2025-09-24 |
| Classified | 2025-10-02 |
| Reported by FDA | 2025-10-08 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 68382-0920, 68382-0920-01, 68382-0920-06, 68382-0920-16, 68382-0920-30, 68382-0920-77, 68382-0921, 68382-0921-01, 68382-0921-06, 68382-0921-16, 68382-0921-30, 68382-0921-77 |
| Lot numbers | E409308 |
| Expiration dates | 2026-12-31 |
Product
Entecavir Tablets, USP, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-920-06.
Reason for recall
Failed impurity/degradation specifications:Out of Specification result for an individual organic impurity
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0001-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.